CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
NCT ID: NCT05257590
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
95 participants
INTERVENTIONAL
2022-05-23
2026-03-31
Brief Summary
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Detailed Description
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To meet the medical need, TaiRx, Inc. develops a new small molecule drug, CVM-1118 can promote apoptosis and delay proliferation. Moreover, CVM-1118 targets the formation of vasculogenic mimicry (VM). VM has been associated with tumor metastasis and poor clinical outcomes. VM is reported to be particularly active in tumor under hypoxia state when patients are treated with the potent vascular endothelial growth factor (VEGF) inhibitor like sorafenib or bevacizumab. Hence, the ability of inhibiting the VM network makes CVM-1118 a potential good combination drug with Nivolumab in advanced diseases such as hepatoma where Nivolumab alone has shown activity.
The safety profile of CVM-1118 dosing has been established in the phase 1 study. The analysis of metabolism pathways further showed that the potential drug-drug interactions of CVM-1118 and Nivolumab are very low.
Based on the mechanism of actions and the safety analysis of nivolumab and CVM-1118, the design of phase 2 trial with the combination therapy might have great potential for the patients with unresectable advanced HCC.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab + CVM-1118
1 Cycle = 28 days
Nivolumab, 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting from Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.
CVM-1118, 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects. Escalation of the starting dose will be dependent on the absence of Dose Limiting Toxicity in at least 7 of the initial 10 subjects treated at 200 mg, PO, BID.
Individual subjects receiving a starting dose of 200 mg, PO, BID and who tolerate the initial 2 cycles with no more than Grade 2 related toxicity, will have the option of increasing their dose of CVM-1118 to 300 mg, PO, BID (600 mg total daily dose) starting with cycle 3
Tolerable dose of Nivolumab and CVM-1118 will be administered continuously for a 28-day cycle until progressive disease, unacceptable toxicity, or consent withdrawal.
Nivolumab Injection [Opdivo]
Nivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.
CVM-1118
CVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.
Interventions
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Nivolumab Injection [Opdivo]
Nivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.
CVM-1118
CVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hepatocellular carcinoma
* Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
* Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
* Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
* Child-Pugh liver function class A
* Measurable disease (per mRECIST)
* ECOG performance status of 0 to 1
* Adequate laboratory parameters including:
* AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)
* Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)
* ANC ≥1500/µL
* Platelets ≥ 90,000/µL
* HGB ≥ 9.0 g/dL
* Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula
* Serum albumin ≥ 2.8 gm/dL
* INR ≤ 2.3
* PT/aPTT ≤ 1.2 x ULN
* QTcF ≤ 480 msec
* Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows:
* Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA \<500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent.
* Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.
Exclusion Criteria
* Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
* Prior immunotherapy for hepatoma
* ≤ 7 days from prior limited field palliative irradiation therapy and C1D1
* ≤ 28 days from prior irradiation therapy and C1D1
* ≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1
* ≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1
* Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints
* Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1
* Known CNS metastases
* Known history of HIV infection
* Females who are currently pregnant or breast-feeding
* Known gastrointestinal disease that may significantly alter the absorption of oral medications
* Psychiatric illness or social situation that would interfere with compliance with study requirements
* History of clinically significant cardiovascular abnormalities
18 Years
ALL
No
Sponsors
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TaiRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pei-Jer Chen, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Sheng-Nan Lu, MD/Ph.D
Role: primary
Kun-Yun Yeh, MD/Ph.D
Role: primary
Yan-Shen Shan, MD/PhD
Role: primary
Pei-Jer Chen, MD/PhD
Role: primary
Yi-Hsiang Huang, MD/PhD
Role: primary
Other Identifiers
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CVM-008
Identifier Type: -
Identifier Source: org_study_id